12- month follow-up:
Over 75% of patients improved at 12 months (>50% pad weight reduction) and Over 44% of patients (50/113) became dry at 12 months.
5-year follow-up shows efficacy is maintained:
65% of patients (42/65) maintained improvement in Continence Grade from year 2 and 71% of patients (39/55) considered their symptoms had “improved” or “remained the same” by year 5.
This product was first launched in 1999
Estimated number of patients treated: Over 100,000 procedures worldwide
NICE Guidelines in Urinary Incontinence suggest considering intramural bulking agents, including those of carbon coated zirconium beads, for the management of SUI if conservative management has failed.
NICE Guidelines, Urinary Incontinence: The management of urinary incontinence in women (CG171, published September 2013).
|Material||Pyrolytic Carbon Coated Beads||Polydimethyl
|U.S 5 year follow up data||Yes|
|No special equipment||Yes|
|Contraindicated – Fragile Urethral Mucosal Lining||Yes||Yes|
Pyrolytic Carbon Coated Beads
|Pad Weight – > 50% improvement||75.2%||63.9%||53.2%||61.8|
|Pad Weight – Dry||44.3%||Not Reported||24.0%||28.2%|
|Pad Weight – Worsening or no change||12.4%||28.7%||Not Reported||29.0%|
|Stamey – > 1 grade improvement||66.1%||61.5%||Not Reported||63.4%|
|Stamey – Dry||31.3%||36.9%||47.2%*||38.9%|
DURASPHERE injectable bulking agent is composed of pyrolytic carbon coated graphite beads suspended in a water-based carrier gel (2.8% Glucan) conveniently packed in sterile 3 ml syringes.
Unlike some bulking agents, pyrolytic carbon-coated graphite beads will not be degraded by the body, so the bulking effect is maintained, and the procedure does not need to be repeated annually.
No Migration observed at 1- or 2-year follow-up
No evidence of migration was observed from the patient kidney, urethra and bladder X-rays taken at 12 months (n=100) and 24 months post treatment.
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